Home / Recalls / Applied Medical Resources Corp / Z-1847-2020

Z-1847-2020 Class I Terminated

Recalled by Applied Medical Resources Corp — Rancho Santa Margarita, CA

Recall Details

Product Type
Devices
Report Date
May 13, 2020
Initiation Date
October 24, 2019
Termination Date
June 1, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28,799 catheters in total

Product Description

Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10Y

Reason for Recall

The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

Distribution Pattern

Worldwide distribution - United States: Nationwide OUS: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Poland, Saudi Arabia, South Africa, Spain, Taiwan, United Kingdom

Code Information

Model CE0340DR, BARD CATHETER, lot numbers 1276248, 1283930, 1284935, 1286527, 1295731, 1317372, 1326198 Model CE0380DR, BARD CATHETER, lot numbers 1253338, 1260036, 1263505, 1268151, 1276218, 1283938, 1289018, 1299712, 1301797, 1308727, 1312145, 1314562, 1324334, 1335171 Model CE0440DR, BARD CATHETER, lot number 1286829 Model CE0480DR, BARD CATHETER, lot numbers 1263515, 1268153, 1276227, 1283943, 1284950, 1289021, 1293173, 1299711, 1301798, 1308737, 1312147, 1312986, 1318084, 1325785 Model CE0540DR, BARD CATHETER, lot numbers 1284054, 1284951, 1328361 Model CE0580DR, BARD CATHETER, lot numbers 1255414, 1263517, 1276230, 1283948, 1286831, 1289126, 1295732, 1301799, 1308735, 1317737, 1318091, 1325790, 1335172 Model CE0680DR, BARD CATHETER, lot numbers 1250869, 1260041, 1268157, 1276234, 1283950, 1284954, 1289024, 1295730, 1303736, 1308740, 1314577, 1318092, 1324358

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  • Z-1388-2024 Class II — Epix Universal Clip Applier, REF: CA500, STERILEEO (January 30, 2024)
  • Z-1389-2024 Class II — Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following (January 30, 2024)
  • Z-2158-2020 Class II — Epix latis GRASPER, 5 mm x 35 cm, REF C4130, Qty: 10, Sterile R, CE, Rx ONLY, U (March 17, 2020)
  • Z-2160-2020 Class II — DR. THAMES - LAP CHOLE, REF: K0880, UDI: (01)30607915139620 (March 17, 2020)
  • Z-2159-2020 Class II — Epix latis GRASPER, 5mm x 45 cm, REF: C4140, Qty: 10, Sterile R, CE, Rx ONLY, UD (March 17, 2020)
  • Z-2161-2020 Class II — Clip Applier Kit, REF: K2887, UDI: (01)30607915139132(17)220822(30)1(10) (March 17, 2020)
  • Z-2036-2020 Class II — STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - P (January 31, 2020)
  • Z-2034-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - P (January 31, 2020)
  • Z-2035-2020 Class II — STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - P (January 31, 2020)